ALCOHOL EDUCATION PROJECT GRANTS (R25) RELEASE DATE: July 20, 2004 PA NUMBER: PAR-04-129 (See Modification PAR-07-001) EXPIRATION DATE: September 18, 2006 (Expired September 18, 2006 per NOT-OD-06-104) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.273 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Supplementary Instructions o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports research programs to advance understanding of the biological and behavioral processes involved in the development, expression, and consequences of alcoholism and other alcohol-related problems. The Institute also supports prevention, treatment, and health services research on alcohol abuse and alcoholism. A part of the NIAAA mission is the dissemination of new knowledge acquired from alcohol research to diverse audiences including scientists; educators; clinicians and other health and social service providers; patients and their families; professionals within the criminal justice system; and the general public. This Program Announcement (PA) identifies health education activities that NIAAA will consider for award through Education Project Grants (R25). RESEARCH OBJECTIVES Broad ranges of educational approaches are included within the context of this PA. The major areas of activity include: With respect to K-12 programs specifically, the following criteria should be considered: A.)K-12 Science Education and Undergraduate/Graduate Education- Educational activities directed toward enhancing the knowledge of primary/secondary school educators and/or students and/or undergraduate/graduate students on the science of alcohol and/or alcohol-related problems. Activities and projects under this objective should attempt to meet criteria as detailed below: 1. Applicants are highly recommended to include K-12 teachers and related educators as consultants or as members of the development team. 2. For K-12 programs, materials developed should be easily integrated into an existing school’s curriculum, using between two and five class periods for implementation, depending upon the type of scheduling that exists within the school system (thus, block scheduling and related scheduling models should use no more than two class periods; regular scheduling may use up to five) 3. For K-12 programs, materials should align with National Science Education Content and Teaching Standards (NSES) at least, and if possible, with AAAS’ Benchmarks for Science Literacy 2061. 4. For K-12 programs, materials should be readily adaptable to specific state standards in the initial state(s) that the material is to be proposed for use or pilot/field testing. Incorporated state standards, such as McRel, should be used as a guideline for future potential national implementation 5. Multimedia components are encouraged, especially those that use innovative, cutting-edge technology. However, use of multimedia must not be at the expense of science content and educational methodology. In addition, submissions must also be flexible for underprivileged classrooms (in the case of K-12 programs) and/or school districts that may not have availability of certain multimedia devices or adequate student to computer ratios. 6. For K-12 programs, lessons, though targeted towards a certain age- level, should be adaptable to diverse student bodies, to promote greater usability. Specifically, teachers are faced with inclusion classrooms that are made up of gifted students, English as a Second Language (ESL/ESOL) students and students with a wide variety of mental and physical disabilities among others. Submissions should have activities that while promoting inquiry, also differentiate to various degrees (i.e. open-ended, guided and structured inquiry model) as a preference. 7. Evaluation components to assess student learning, teacher usability and ease of implementation, as well as measured changes with respect to related state and/or national standardized exam scores, must be included. Evaluations need to provide a fair, balanced comparison (control groups must be provided with adequate references and resources on content) that allows for an accurate assessment of improvement. Grantees should be willing to work with administrators and policy makers, and through doing so, develop an evaluation piece that is conducted throughout the developmental process, targeting not only academic improvement, but more importantly how the product is being used (feasibility, time spent using it in class, adoptability to other courses/grades, etc). Finally, survey questions should be provided and collected from both teachers (especially) and students to be used for further modifications and updated editions of the curricula itself, especially if applicants are seeking continuation awards. The remaining criteria should be pertinent to both K-12 and undergraduate/graduate academic environments: Materials should include a background section (does not need to be substantial in length) for teachers that accounts for the technical content included and provides assistance with preparation and implementation of the activities. Teacher materials need to be developed to the degree that teachers require only minimal preparation to learn about and implement the lesson(s). This may vary to a degree with respect to undergraduate/graduate school programs. In addition, teacher training sessions/workshops should be developed as part of the grant submission. Material should have a targeted grade/age level. Pilot and field testing should be done in various socioeconomic rural, urban and suburban school settings to determine student and teacher feasibility and interest, and must include and account for feedback from both. In addition, these materials should be inquiry-based and constructivist in nature. The 5E’s Instructional Model (Engage, Explore, Explain, Elaborate and Evaluate) is encouraged for design purposes in K-12 educational programs. It is anticipated that one of the results of these projects will be publications submitted to appropriate science education research journals. In addition, it is desirable that products that are developed under this mechanism be shared with NIAAA for use on both the NIAAA and NIAAA Cool Spot (adolescent) websites, as well as for use in various science teacher workshops, trainings, conferences and presentations. Project members should work with teachers and/or professors on integration of programs, but also on actual instruction in the classroom. Thus, focus group testing should involve the PI or other qualified member of the team providing actual instruction of developed module(s) to K-12 classrooms and college environments, in various settings. B.) Health Professions Education- This area of activity includes projects designed to support and study the dissemination of new knowledge acquired through alcohol research to a wide array of health professionals—both individuals currently practicing their professions and those in training for health professions. A broad definition of health professions is adopted, including but not necessarily limited to: social workers, occupational therapists, nurses, physicians, psychologists, counselors, and others involved in areas of physical, mental and/or behavioral health services where target groups experience alcohol use disorders. Appropriate activities may include, but are not limited to, the development of courses, program, curricula, and related materials designed to educate scientists, educators, service providers, and others about scientific advances in our knowledge of alcoholism, alcohol abuse, and alcohol-related problems (for example health-related complications with individuals who have diabetes and consume alcohol). Activities and projects under this objective should attempt to meet the criteria as detailed below: 1) Applicants are strongly encouraged to include members of the target health professions audience as consultants or in the planning process; 2) Educational intervention innovations and materials should be transferable, adoptable, and adaptable by educators in health profession training settings other than those where they have been initially pilot tested; 3) Educational innovations should address relevance and relatedness to current and/or emerging standards for education in the target profession; 4) Evaluation components must address outcomes and be conducted using appropriate types of research designs, instrumentation, procedures, sampling strategies, and plans for analyses; and 5) Products developed under this mechanism may be shared with NIAAA for use and dissemination through its websites, workshops, trainings, conferences, and presentations. C.) Public Health Education- Educational activities directed to patients, their families, and the general public, which impart knowledge gained through research on alcohol-related health issues, including those related to screening, treatment, and prevention. The development of materials designed to increase the health of the general public and their knowledge of scientific advances. In particular, programs targeted toward 18-24 year olds are encouraged, given that this is known to be a high-risk drinking period. The translation of scientific knowledge into practice is important to make our research findings have more significant meaning. MECHANISM OF SUPPORT This Program Announcement (PA) uses the National Institutes of Health (NIH) Education Project Grant (R25) mechanism. As an applicant you will be solely responsible for planning, directing and executing the proposed project. The total project period for an application submitted in response to this PA is generally two years, though if strong, an exception could be made (if justification is provided) to allow for funding not to exceed five years. Competing renewal applications may be submitted for additional years beyond the initial project period. The maximum award will be $250,000 in direct costs per year. Indirect costs will be paid at 8% of direct costs, less appropriate exclusions. It is anticipated that two to three R25 awards will be available annually. Given the diverse nature of activities supported under this PA, the size of awards will vary. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAAA, awards pursuant to this PA are contingent upon the availability of funds for this purpose. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. These awards are not renewable; however, a no-cost extension of up to one year may be granted to the grantee institution prior to expiration of the project period. Investigators are encouraged to seek continued support for their research projects through a research project grant (R01). ELIGIBILE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Faith-based and community-based organizations o Foreign institutions are not eligible to apply Small Business organizations are eligible to apply for alcohol science education projects through the Small Business Innovative Research (SBIR) or Small Business Technology Transfer (STTR) programs. Information on the SBIR and STTR programs is available at http://grants.nih.gov/grants/funding/sbir.htm and from the NIAAA program official listed under INQUIRIES. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS (ALLOWABLE COSTS) Allowable costs must be consistent with NIH policy and be reasonable, allowable, and well-documented and justified for the research education program. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Personnel Costs - individuals participating in the design and implementation of the alcohol education project may request salary and fringe benefits appropriate for the percent of time devoted to the program. Normally, all personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 25% of the total direct cost. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Consultation costs, equipment, supplies, necessary travel, and other program-related expenses must be justified as specifically required by the program proposed and not duplicate items generally available for educational programs at the host institution. Participant Support - participants in the alcohol education project may receive subsistence allowance, which includes partial costs of meals and lodging (unless furnished as part of the fee for registration). Individuals supported by NIH training and career development mechanisms (K, T or F Grants) may not receive stipend or salary support from the Alcohol Education Project Grant. However, if funds are not available from other sources, limited support to defray participation costs (e.g., travel, meals, lodging) may be provided. Partial costs for off-site rental space will be considered if it is short-term and shown to be necessary for the implementation and execution of the educational program (seminar, workshop, etc.). Matching funds from applicant institutions or other organizations for such off-site costs are strongly encouraged. Facilities and Administrative (F&A) Costs, formerly known as "indirect costs," may be allowed for the applicant organization and any approved subcontract based on 8% of total direct costs exclusive of tuition and fees and expenditures for equipment. Normally, funds will not be provided for fringe benefits or health insurance for participants involved in this education program. Note that all costs associated with consortium/contractual arrangements, both direct and F&A costs are considered direct costs and are included in the $250,000 direct costs ceiling limitation for this program. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: programmatic and financial or grants management issues. Inquiries concerning Education Project Grants focused on K-12 Science Education and Undergraduate/Graduate Education should be directed to: Jason Lazarow, M.Ed. Science Education Coordinator Health Sciences Education Branch Office of Research Translation and Communications National Institute on Alcohol Abuse and Alcoholism National Institutes of Health (note new physical address) 5635 Fishers Lane Room 3101, MSC 9304 Bethesda, MD 20892-9304 (For FedEx/UPS, use Rockville, 20852-1705) Telephone: (301) 435-8043 Fax: (301) 480-1726 Email: jlazarow@mail.nih.gov Inquiries concerning Education Project Grants focused on Health Professions Education: Isabel Ellis, MSW Public Health Analyst Health Sciences Education Branch Office of Research Translation and Communications (ORTC) National Institute on Alcohol Abuse & Alcoholism National Institutes of Health (note new physical address) 5635 Fishers Lane Room 3111, MSC 9304 Bethesda, Maryland 20892-9304 (For FedEx/UPS, use Rockville, 20852-1705) Telephone: (301) 443.8771 FAX: (301) 480.2358 Email: iellis@mail.nih.gov Inquiries concerning Education Project Grants focused on Public Health Education should be directed to: Margaret M. Murray, MSW Chief, Health Sciences Education Branch Office of Research Translation and Communications National Institute on Alcohol Abuse and Alcoholism National Institutes of Health (note new physical address) 5635 Fishers Lane Room 3105,MSC 9304 Bethesda, MD 20892-9304 (For FedEx/UPS, use Rockville, 20852-1705) Telephone: (301) 443-2594 Fax: (301) 480-1726 Email: pmurray@mail.nih.gov Inquiries regarding fiscal matters should be directed to: Judy Fox Grants Management Branch National Institute on Alcohol Abuse and Alcoholism National Institutes of Health (note new physical address) 5635 Fishers Lane MSC 9304 Bethesda, MD 20892-9304 (For FedEx/UPS, use Rockville, 20852-1705) Telephone: (301) 443-4704 Fax: (301) 443-3891 Email: jfox@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. The PA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. SUPPLEMENTARY INSTRUCTIONS Applications that do not conform to the specific instructions detailed below will be returned without review. 1. Application face page: item number two on this page must include the program announcement number and the title, Alcohol Education Project Grant (R25). 2. Description, Performance Sites, and Key Personnel (Form Page 2): under Performance Sites include "Consortium/Contractual Arrangements," with a description of plans for collaborating with other institutions for purposes of exchange and sharing of resources, including faculty, equipment, and facilities. If multiple sites are to be used, the applicant institution must be one of those sites and for other sites a strong justification must be included. 3. Resources (Resources Format Page): describe the educational environment; include a description of the facilities, laboratories, participating departments, computer services, and any other resources to be used in the conduct of the proposed education program. Use continuation pages, as necessary. 4. Education Plan: a) Program Direction - describe arrangements for the organization and administration of the program, as well as evidence of institutional and community commitment and support for the proposed program. b) Program Faculty/Staff - describe the characteristics and responsibilities of the faculty; provide evidence that the applicant and/or supporting personnel (including consultants) are actively engaged in research or other scholarly activities related to alcohol abuse and alcoholism. NIAAA recommends a multidisciplinary advisory group that would include addiction specialists, prevention researchers and experts in an appropriate related educational field. The primary responsibility of this advisory group is the recruitment and selection of curriculum specialists, teachers, school administrators, and students as appropriate. c) Program Participants - provide detail about the proposed participants; include a description of plans for recruiting individuals from underrepresented racial/ethnic groups, women and persons with disabilities. Competing continuation applications must include a detailed account of experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. d) Education Evaluation Plan – education evaluation plans are encouraged in determining the success of the program in achieving its goals and objectives. Pilot testing and field testing is highly recommended as part of the evaluation plan, including pre- and post- tests, and surveys. Please note that applications that do not have an adequate education evaluation plan will be considered non-responsive to this program announcement. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Institute on Alcohol Abuse and Alcoholism Advisory Council. REVIEW CRITERIA The goals of NIH-supported Alcohol Education projects are to enhance the exposure and understanding of K-12 students and their teachers (or appropriate intended audiences), as well as the general public to basic research and its outcomes and implications. One of the major intents of NIAAA’s educational programs is to increase the number of individuals who will pursue biomedical careers generally, and alcohol research careers specifically. To this end, NIAAA also encourages the recruitment of underrepresented minorities and underserved populations. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed project will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Evaluation o Personnel o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Briefly summarize the background leading to the development of this plan. Explain why the particular strategy was chosen. Include information on the process and rationale for selecting the scientific area, the educational approach, and the target population, and indicate how this project will address an unmet need. o Describe the advantages and limitations of the model selected, and its potential for widespread dissemination and adaptability for use by others. APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? IN ADDITION ALL PROJECTS SHOULD HAVE THE FOLLOWING: o Identify the long-range goals for the project and describe the specific objectives for the proposed project period. o Include preliminary studies relevant to your application conducted by the principal investigator and/or other key personnel. In addition, provide other relevant information that will establish the experience and competence of both the program leadership staff and partnership organizations to effectively carry out the proposed project. o A description of the educational approach, the scientific content, and the nature and extent of existing educational and scientific partnerships and collaborative interactions. o A description of any dissemination activities to date, or a description of the stage of development of the current model with respect to future dissemination plans. PROPOSED PLAN: o Describe in detail the activities proposed and how they will contribute to achieving the stated goals of the program. o Give quantitative data on the numbers of teachers, students, and/or members of the general public projected to be involved and the quantity and types of educational materials to be produced and/or disseminated. o Explain the relevance and potential of this project for dissemination to a broad population, including efforts aimed at underrepresented groups in science, both women and minorities. o Explain clearly the nature and extent of educational and scientific partnerships and collaborations to be developed (or, for those already established, any plans for expansion or modification), and the roles of key participants in the planning and conduct of the project. o Provide documentation of the interest and commitment of members and participants to this project. o Discuss how the proposed educational programs or research project is both appropriate and adequate to achieve the educational goals outlined. o Describe the administrative plan to organize and manage the overall project, and provide a timetable for the various tasks and activities for the entire project period requested. EVALUATION: All applications must include a detailed Evaluation Plan for assessing the success of the proposed educational program. The Evaluation Plan should be an integral component of the early planning stages and must continue through the life of the project. The use of external evaluators is required unless a valid justification can be made for an internal evaluation team. o Provide a detailed plan for evaluating the effectiveness of the program in achieving its objectives. o Document that the evaluation team is appropriate and qualified for your proposed project. o Describe the development and implementation of the plan for formative and summative evaluations of project activities. Include strategies for revisions to evaluative instruments and educational processes and/or materials. INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Discuss how the curriculum, educational, research and/or collaborative plans include original and unique approaches for addressing the needs put forth in the goals and objectives. o Present your plan to include related learning tools, such as teamwork, writing and mathematics skills, inquiry-based thinking and problem solving under the umbrella of your main science education topic. If appropriate discuss your plans to challenge existing science education paradigms or to develop new approaches for improving science literacy. PERSONNEL: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? o Present a discussion as to how the program leadership has demonstrated a record of achievements and that their qualifications are appropriate to achieving the proposed goals and implementing the stated plan. o Discuss how the K-12 partners will provide input in the proposed program with respect to educational content, sophistication level of the students and relevance to state and national testing standards. As appropriate letters of participation and support from collaborators, school officials and teachers must be included as Appendix materials. ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? o Discuss how the inquiry-based scientific and educational environment described in your proposal will foster student interest and participation, increase the awareness of the scientific process and ultimately generate a high level of confidence in the students for health science related careers. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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